Inkine Pharmaceutical (NASDAQ:INKP)
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InKine Pharmaceutical Company, Inc. (Nasdaq: INKP):
Highlights
-- Entered into a definitive merger agreement with Salix
Pharmaceuticals, Ltd.
-- Filed New Drug Application (NDA) for next generation purgative
product - INKP-102
-- Grew quarterly revenues by 16% to $5.7 million for Q2 2005,
compared to $4.9 million for Q2 2004
-- Generated quarterly prescription growth of approximately 23%
for Q2 2005 compared to Q2 2004
InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced
its second quarter 2005 financial results, reporting second quarter
product revenue of $5.7 million, compared to $4.9 million for the same
period a year ago. The Company was not profitable for the quarter and
six-months ended June 30, 2005 as a result of its decision to
accelerate the development and filing of its NDA to FDA for its next
generation purgative product, INKP-102. InKine incurred losses of $0.6
million or $0.01 per share and $0.3 million or $0.01 per share for the
quarter and six-months ended June 30, 2005, compared to net income of
$1.0 million or $0.02 per share for both the quarter and six-months
ended June 30, 2004.
"During the second quarter, in addition to entering into a
definitive merger agreement with Salix Pharmaceuticals, Ltd., we
submitted and the FDA recently accepted for filing our NDA for our
next generation purgative tablet, INKP-102," said Leonard S. Jacob,
M.D., Ph.D., Chairman and Chief Executive Officer of InKine. "We
believe that although the acceleration of our research and development
efforts for INKP-102 affected our ability to be profitable for the
six-months ended June 30, 2005, if INKP-102 is approved by FDA, our
investment in this important drug will positively impact the revenue
growth of the franchise," Dr. Jacob added.
Gross Profit:
-- Product revenues were $5.7 and $10.9 million for the quarter
and six-months ended June 30, 2005, a 16% and 18% increase,
respectively, over product revenues of $4.9 and $9.2 million
for the same periods a year ago. Prescription levels have
escalated as a result of increased sales and marketing
efforts, which continue to grow market awareness and
acceptance of Visicol(R). Approximately 145,000 prescriptions
were filled for Visicol(R) during the second quarter of 2005,
which represents an increase of approximately 23% over
prescriptions of 118,000 for the second quarter of 2004.
-- In addition to product revenue, the Company realized $818,000
in other revenue for the first half of 2005, which was
primarily attributable to a milestone payment received from
Zeria Pharmaceutical Company, our licensee for the use and
sale of Visicol(R) in Japan.
-- Gross profit was $4.8 and $10.0 million for the quarter and
six-months ended June 30, 2005, compared to $4.6 and $8.8
million for the same periods a year ago. Gross profit as a
percentage of sales for product revenue was 85% and 84% for
the three and six-months ended June 30, 2005, compared to 87%
and 88% for the same periods a year ago. The decreases in
gross profit as a percentage of product sales were the result
of increased royalty expense recognized along with
distribution costs payable to wholesalers.
"Prescriptions grew by 25% for the first half of 2005, compared to
the first half of 2004," said Robert F. Apple, Chief Operating and
Financial Officer of InKine. "As of June 30, 2005, we had
approximately $13.0 million in cash and investments, 41 days
outstanding in receivables, sufficient inventory to meet customer
demand and no outstanding debt," added Mr. Apple.
Costs and Expenses:
-- Research and development costs were $2.0 and $3.8 million for
the quarter and six-months ended June 30, 2005, compared to
$1.0 and $2.0 million for the same periods a year ago. The
increases were the result of development costs associated with
the clinical studies and NDA filing of InKine's next
generation MCC-free purgative tablet, INKP-102, along with
higher costs related to an increased scale of development
activity.
-- Sales and marketing costs were $2.6 and $4.9 million for the
quarter and six-months ended June 30, 2005, compared to $2.2
and $4.1 million for the same periods a year ago. The
increases were the result of continued growth in the size of
InKine's sales force, along with increased marketing campaigns
related to Visicol(R). As of June 30, 2005, the InKine's sales
force covered 50 territories with five district managers,
compared to 45 territories and four district managers as of
June 30, 2004.
-- General and administrative costs were $1.0 and $1.9 million
for the quarter and six-months ended June 30, 2005, compared
to $0.7 and $1.5 million for the same periods a year ago. The
increases were the result of higher personnel, patent and
insurance costs, along with increased legal and accounting
fees associated with maintaining compliance with the
Sarbanes-Oxley Act of 2002.
-- During the quarter ended June 30, 2005, InKine received final
court approval in connection with its litigation with a class
of holders of InKine equity shares who alleged they were
denied certain claimed preemptive rights. In addition, during
the quarter ended June 30, 2005, InKine received final
reimbursement from a third-party for costs incurred in
connection with the class action litigation and accordingly,
InKine reversed its $200,000 insurance deductible accrual upon
receipt of the final reimbursement from the third-party.
Balance Sheet:
-- InKine had $13.0 million in cash and investments and no
balance outstanding on its line of credit at June 30, 2005.
Merger Update:
-- As previously announced on June 23, 2005, InKine entered into
a definitive agreement and plan of merger with Salix
Pharmaceuticals, Ltd. (Salix) and Metal Acquisition Corp., a
wholly-owned subsidiary of Salix. Consummation of the merger
is subject to approval by InKine's shareholders of adoption of
the merger agreement and approval by Salix's stockholders of
the issuance of Salix common shares in the merger, expiration
or termination of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended (HSR Act) and other customary closing conditions. Also
as previously announced, the pending merger with Salix is
currently expected to close during the fourth quarter of 2005,
however, InKine cannot assure you that the merger will be
consummated.
-- On July 19, 2005, Salix filed with the Securities and Exchange
Commission (SEC) a registration statement on Form S-4
containing a joint proxy statement/prospectus relating to the
proposed merger.
-- On July 28, 2005, InKine received notification of early
termination of the waiting period under the HSR Act.
About InKine Pharmaceutical
InKine Pharmaceutical Company, Inc. is a publicly traded specialty
pharmaceutical company focused on developing and commercializing
pharmaceutical products for the diagnosis and treatment of
gastrointestinal disorders. The InKine's development strategy has been
to acquire late-stage drug candidates with short time lines to
commercialization. InKine's franchise product, Visicol(R) is the only
tablet purgative preparation indicated for bowel cleansing prior to
colonoscopy. InKine's second product, IB-Stat(R), is an oral
hyoscyamine spray for the treatment of a variety of indications.
Additionally, InKine is developing INKP-102, an advanced generation
purgative, for which we recently submitted a new drug application to
FDA for bowel cleansing prior to colonoscopy and developing Visicol(R)
for use as a laxative in treating patients with chronic constipation.
For further information, please visit InKine on its web site
http://www.inkine.com.
This press release contains forward-looking statements, including
statements regarding our expectations regarding INKP-102 and its
potential positive impact on our revenue, our proposed merger with
Salix, including the timing of consummation, if any, of the proposed
merger, and the sufficiency of our inventory. Such forward-looking
statements are based on InKine's current expectations or forecasts of
future events. InKine's performance could differ materially from those
reflected in these forward-looking statements due to general
financial, economic, regulatory and political conditions affecting the
biotechnology and pharmaceutical industries the timing of FDA review
of INKP-102, InKine's ability to commercialize INKP-102 and grow
product revenue and the effects of the other risks and uncertainties
set forth in InKine's reports on Form 10-Q and 10-K filed with the
U.S. Securities and Exchange Commission. Given these risks and
uncertainties, any or all of these forward-looking statements may
prove to be incorrect. Therefore, you should not rely on any such
factors or forward-looking statements. Furthermore, InKine may elect
to update forward-looking statements, but InKine disclaims any
obligation to do so.
Additional Information
In connection with the merger between Salix and InKine, Salix has
filed with the SEC a registration statement on Form S-4, containing a
joint proxy statement/prospectus and other relevant materials.
INVESTORS AND SECURITY HOLDERS OF SALIX AND INKINE ARE URGED TO READ
THE JOINT PROXY STATEMENT/PROSPECTUS AND THE OTHER RELEVANT MATERIALS
BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT SALIX, INKINE AND THE
MERGER. The joint proxy statement/prospectus and other relevant
materials, and any other documents filed by Salix or InKine with the
SEC, may be obtained free of charge at the SEC's web site at
www.sec.gov. In addition, investors and security holders may obtain
free copies of the documents filed with the SEC by Salix by directing
a request to: Salix Pharmaceuticals, Ltd., 1700 Perimeter Park Drive,
Morrisville, North Carolina 27560, Attn: Investor Relations. Investors
and security holders may obtain free copies of the documents filed
with the SEC by InKine by contacting InKine Pharmaceutical Company,
Inc., 1787 Sentry Parkway West, Building 18, Suite 440, Blue Bell,
Pennsylvania 19422, Attn: Investor Relations
Salix, InKine and their respective executive officers and
directors may be deemed to be participants in the solicitation of
proxies from the stockholders of Salix and shareholders of InKine in
favor of the merger. Information about the executive officers and
directors of Salix and their ownership of Salix common stock is set
forth in the proxy statement for Salix's 2005 Annual Meeting of
Stockholders, which was filed with the SEC on April 29, 2005.
Information about the executive officers and directors of InKine and
their ownership of InKine common stock is set forth in the proxy
statement for InKine's 2005 Annual Meeting of Shareholders, which was
filed with the SEC on May 2, 2005. Investors and holders of Salix and
InKine common stock may obtain more detailed information regarding the
direct and indirect interests of Salix, InKine and their respective
executive officers and directors in the merger by reading the joint
proxy statement/prospectus regarding the merger.
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InKine Pharmaceutical Company, Inc.
CONDENSED STATEMENTS OF OPERATIONS
(amounts in thousands, except per share amounts)
(unaudited)
Three-Months Six-Months
Ended Ended
June 30, June 30,
-------------- ---------------
2005 2004 2005 2004
-------------- ---------------
Product revenue $5,650 $4,891 $10,868 $9,241
Other revenue --- 375 818 658
-------------- ---------------
Revenue 5,650 5,266 11,686 9,899
Cost of goods sold (862) (652) (1,710)(1,143)
-------------- ---------------
Gross profit 4,788 4,614 9,976 8,756
Cost and expenses:
Research and development 1,993 1,036 3,762 1,958
Sales and marketing 2,621 2,160 4,909 4,109
General and administrative 1,031 692 1,908 1,477
Withdrawn public offering and
litigation (200) (338) (200) 229
-------------- ---------------
Operating expenses 5,445 3,550 10,379 7,773
-------------- ---------------
Income (loss) from operations (657) 1,064 (403) 983
Interest income and expense 80 15 140 18
-------------- ---------------
Net income (loss) $(577)$1,079 $(263)$1,001
============== ===============
Net income (loss) per share - basic
and diluted $(0.01) $0.02 $(0.01) $0.02
============== ===============
Weighted average shares
outstanding - basic 49,111 48,676 49,109 48,611
Weighted average shares
outstanding - diluted 49,111 53,504 49,109 53,737
CONDENSED BALANCE SHEETS
(amounts in thousands)
June 30, December 31,
2005 2004
----------- ------------
ASSETS (unaudited)
Cash and investments $13,018 $13,053
Accounts receivable 2,550 2,264
Inventory 1,635 1,445
Other assets 817 622
----------- ------------
Total assets $18,020 $17,384
=========== ============
LIABILITIES AND SHAREHOLDERS' EQUITY
Accounts payable and accrued expenses $3,735 $3,016
Shareholders' equity 14,285 14,368
----------- ------------
Total liabilities and shareholders'
equity $18,020 $17,384
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